All devices, instruments and accessories used for medical purposes (collectively “medical devices”) require varying degrees of cleaning, disinfection and sterilization before the devices can be reprocessed and reused on the same patient, or between patients. In particular, devices with passageways, such as hoses and tubes, are particularly difficult to reuse as the inner space of the passageway, is difficult to completely clean, disinfect and sterilize. These hard to reach places are particularly prone to bacteria, mold and microorganism build-up as medical devices often have fluid, other devices touching fluids or body parts, water and humidified water passing through the passageways. As such, there is a need for devices, systems and methods that solves the need to clean, disinfect and sterilize multiple medical devices, including the inner passageways of medical tubes.
Institutions such as hospitals, surgical centers, medical test centers, sleep centers, nursing homes and the like often have the need to reuse medical devices between patients. In hospitals, for example, a variety of devices may require a specific level of cleaning, disinfection, sterilization or a combination thereof before those devices can be reused on the same patient or between patients. Non-compliance with required cleaning, disinfecting, and sterilizing schedules by institutions may result in serious risk to a patient. Currently, institutions have no ability to clean, disinfect, and/or sterilize multiple medical devices, to assure that all of the device parts are ready to be reused in accordance with the devices risk of microbial, microorganism infection and soil build-up. Institutions thus often dispose of medical devices, and use new devices on each patient or between uses on the same patient, resulting in a significant expense. Alternatively, institutions often hire employees to wash devices, in specialized solvents, also resulting in a significant expense for the institution along with a possible margin of error.
Medical devices can be classified in terms of potential risk of infection towards a patient or between patients if the medical device is reused. As an example medical devices may be classified as critical, semi-critical, and non-critical to describe their risk of infection if the devices are reused on the same patient and/or reused between patients. Example of critical devices include but are not limited to, surgical instruments, irrigation systems for sterile instruments in sterile tissues, endoscopes and endoscopic biopsy accessories. These critical devices, for instance, are devices that are introduced directly in the bloodstream or may contact normally sterile tissue and have a possibility of microbial transmission if the medical device is not sterile, thus strict cleaning and sterilization of the medical device is required. Semi-critical devices may be categorized as devices that contact mucous membranes, for example, duodenoscopes, endotracheal tubes, bronchosopes, laryngosopes, blades and other respiratory equipment, esophageal manometry probes, diaphragm fitting rings and gastrointestinal endoscopes, which may require disinfection and/or sterilization before a device can be reused. Non-critical devices are medical devices whose surfaces contacts the skin but do not penetrate the skin. Non-critical devices also include devices that may become contaminated with microorganisms and organic soil during patient care, such as infusion pumps, and ventilators, for example continuous positive airway pressure devices, prone to bacterial build-up because of humidified air and contact with a patient's mouth. Many of the devices listed above include passageways that are difficult to clean, disinfect and sterilize, such as endoscopes, probes, ventilators and specifically continuous positive airway pressure devices and related hoses.
It is thus an object of the present disclosure to provide devices, systems and methods for institutions to clean, disinfect and/or sterilize multiple medical devices. It is also a long-felt need in the art to provide devices, systems and methods that can clean, disinfect and sterilize the inner passageways, tubes and hoses of multiple medical devices while also cleaning, disinfecting and/or sterilizing the outer areas of the medical devices. It is further a long-felt need in the art to indicate to a user at the institution when medical devices are safe to be reused after a treatment cycle. There is also a need to indicate to a user cycle feedback throughout a cleaning, disinfecting and/or sterilizing cycle, to indicate to the user that the device has reached for instance, the maximum level of gas output required to fully sterilize a medical device, allowing the user to know that the devices have been fully sterilized and that there has been no error in reaching the necessary gas sterilization levels and completing a sterilization cycle. There is further a need to provide a device, systems and methods that can attach to any medical device passageway to treat the passageway with ozone gas.
Other systems, methods, apparatus features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, apparatus features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims.